Importers and foreign exporters must provide complete and accurate product information to sail through FDA’s import screening program (PREDICT) and through U.S. Custom’s Automated Commercial Environment (ACE) software program.  Errors create costly delays and fines.  If you do not understand the import process and how to promptly resolve a detention, your product may end up being refused entry and must either be exported or destroyed.

You can negotiate a resolution with the FDA, but you have to know the procedures along with some practical tips that can save you lots of money and grief.  The ultimate delay involves Import Alerts, which brings your U.S. import business to a halt, especially if the foreign firm does not comply with FDA’s applicable regulations.  Removing a firm from Import Alert status is complicated, time consuming and very expensive.  You need to know what you are doing to mitigate the damage to your business.

Course Objective:

You will learn FDA’s import requirements, procedures and tips on how to work with the FDA.  For example:

• Learn what information and computer codes are required by FDA and U.S. Customs.
• Understand the import hold and detention process and how you can resolve the problem by negotiating with the FDA.
• Know what an Import Alert is; what it means for your business, and figure out a realistic business plan.
• Hear some practical tips on how to make your import business less irritating or, in some cases, traumatic.

Areas Covered in the Session:
10:00 a.m. – 12:00 p.m.  Session 1

• FDA’s required information for the PREDICT software screening prior to entry
• Custom’s required information for the ACE software system prior to entry
• FDA product codes and supplemental process code information

12:00 p.m. -- 1:00 p.m.  – Break
1:00 p.m. – 2:30 p.m. – Session 2

• Import holds, what they mean and what happens
• Detentions, what you must do quickly or lose
• Refusals, what your options are
• Negotiating with the FDA

2:30 p.m. – 2:45 p.m.  – Break
2:45 p.m. – 4:00 p.m. – Session 3

• Import Alerts (3 types)
• Consequences of an Import Alert for foreign manufactures
• Foreign manufacturer Warning Letters
• Business strategy around Import Alerts

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Regulatory Directors for International Trade
• Compliance Managers (FDA/Customs)
• Freight Forwarders
• Foreign Manufacturers/Exporters
• Initial Importer in the U.S.
• Small business owners